Quality Management Specialist

vor 3 Wochen


Steinhausen, Zug, Schweiz Wemedoo Vollzeit
Job Description

Wemedoo is a leader in clinical informatics, offering a comprehensive SaaS solution and accompanying professional services for the clinical research industry. Our SaaS solution, oomnia, integrates multiple essential functions for clinical trial management, including EDC, RTMS, ePRO/eCOA, eTMF, eConsent, and CTMS all in a single unified software. Our award-winning professional services include medical writing, data management, eTMF management, and biostatistics. We help a diverse range of clients, including CROs, sponsors, government bodies, NGOs, and academic institutions, enabling them to achieve efficient, high-quality clinical research outcomes.

Key Responsibilities
  • Develop and implement a Quality Management System (QMS) in compliance with ISO 13485, ISO 9001, MDR, and GCP standards.
  • Oversee the creation, updating, and management of QMS documentation, ensuring all processes align with the latest regulatory requirements.
  • Drive internal audits and prepare for external ISO certification audits, ensuring the company meets all necessary compliance standards.
  • Implement and manage quality processes, including CAPA, risk management, and corrective actions, to ensure adherence to ISO 13485 and related standards.
  • Provide training and guidance to staff on ISO requirements and quality best practices, ensuring a company-wide commitment to compliance and quality.
  • Maintain and enhance quality data collection and reporting systems, driving continuous improvement across all functions.
  • Foster and maintain effective working relationships with internal teams and external regulatory bodies to support quality objectives.
Requirements
  • University degree in a scientific field, preferably in chemistry.
  • Extensive knowledge and hands-on experience with ISO 13485, ISO 9001, MDR, and GCP.
  • Several years of quality management experience, ideally within a laboratory environment.
  • Mandatory certification in Quality Management.
  • Proficiency in quality management tools and methodologies, including FMEA, 8D Report, Cause and Effect Diagram, and 5 Why Method.
  • Proven experience in training and mentoring staff on ISO standards and practices.
  • Mandatory certification as an Internal Auditor for ISO standards.
  • Strong attention to detail with excellent organizational skills.
  • Exceptional analytical and problem-solving abilities.
  • Fluent in both English and German.
What We Offer
  • A dynamic and innovative work environment.
  • Opportunities to work with leading-edge technology in clinical research.
  • Professional development and growth within a fast-growing company.
  • Competitive salary, commission structure, and benefits package.


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